Site Visit Lead/Investigator

The Site Visit Lead/Investigator serves as a key clinical professional responsible for planning, conducting, and documenting site visits, both routine and triggered by patient safety investigations, at OPTN member institutions. These site visits can be onsite or virtual and are designed to monitor compliance with OPTN bylaws and policies, ensuring patient safety, data accuracy, and adherence to federal healthcare regulations.

This role requires strong expertise in compliance monitoring, clinical process evaluation, investigations, and stakeholder management. Site Visit Leads/Investigators may work collaboratively with Subject Matter Experts (SMEs) during site visits and may surge to assist with ongoing patient safety investigations as needed.

Key Responsibilities:

The Site Visit Lead/Investigator is responsible for:

Compliance Monitoring:

• Plan and conduct both routine and investigative onsite and desk audits of transplant hospitals, Organ Procurement Organizations (OPOs), and other OPTN member institutions.
• Evaluate adherence to OPTN bylaws, policies, and regulations.

System Assessment:

• Assess defined processes at OPTN member institutions to confirm compliance with expected standards.
• Document findings and recommend corrective actions where necessary.

Planning and Coordination:

• Develop and implement detailed site visit plans, including agendas, schedules, checklists, and team rosters.
• Coordinate logistics with HRSA, site visit teams, and OPTN member organizations to ensure timely and effective visits.
• Ensure required access to staff, documents, workflows, and facilities at OPTN member organizations.
• Collaborate with HRSA and the OPTN Logistics contractor to arrange travel and participant logistics for Subject Matter Experts (SMEs) accompanying site visits.

Site Visit Execution:

• Conduct thorough and timely site visits, whether virtual or onsite, ensuring all activities, such as interviews, observations, and process evaluations, are accurately documented.
• Collect and compile evidence, including medical records, clinical workflows, interviews, and observations, to support case reviews and final decisions.
• Ensure site visits are unbiased and free of conflicts of interest.

Documentation and Reporting:

• Draft and finalize comprehensive site visit reports summarizing findings, actions, and next steps.
• Maintain detailed records of site visit activities, including participant lists, notes, transcripts, recordings, and supporting documentation.
• Submit final site visit reports and supporting documentation to stakeholders within documented deadlines.

Stakeholder Engagement:

• Collaborate with HRSA, OPTN Committees, site visit teams, and OPTN member organizations to ensure effective and fair reviews.
• Support proactive identification and monitoring of conflicts of interest among site visit participants.
• Serve as the primary point of contact for external stakeholders during site visits.

Follow-Up and Monitoring:

• Track site visit progress and status, integrating updates into broader case management tools and reports.
• Align site visit outcomes with ongoing case reviews and oversight processes, ensuring comprehensive follow-through and documentation of corrective actions, escalations, or additional monitoring requirements.

WHAT YOU"LL NEED TO SUCCEED: 

• A Bachelors degree is required
• Registered Nurse (RN) or Social Worker (MSW) preferred
• Requires at least 5 years in compliance, project management, quality improvement, auditing, or investigations within healthcare or regulatory environments
• Requires a background in clinical quality, patient safety, or experience in a transplant-related field.
• Strong understanding of federal, state, and local regulations
• Knowledge of transplant regulations and policies.
• Clinical experience is required, particularly in patient safety, compliance or transplant related environments
• Strong analytical and communications
• Medical chart review
• Strong organizational skills to manage schedules and audit logistics 
• Must be able to travel to member organizations throughout the country (up to 25% of the time)

• Must be able to obtain a Public Trust clearance

LOCATION: Remote

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